Safety Study of Elvucitabine in HIV-1 Subjects

HIV Infections Clinical Trial

Official title:

14-Day Randomized Double-Blind Comparative Viral Kinetic Study of Elvucitabine Versus Lamivudine Once Daily to HIv-1 Subjects With M184V

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405249
• Other study ID #: ACH-443-014A
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2006
• Last updated: February 3, 2009
• Start date: September 2006
• Est. completion date: November 2006

Study information

• Verified date: February 2009
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.

Description:

This is a 14 day on treat/14 day off treatment randomized, double blind viral kinetic study of elvucitabine versus lamivudine administered once daily to HIV infected subjects with a documented M184V variant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• HIV infected, clinically stable, adults

• HIVRNA 5000 -150,000, CD4 100

• Genotypically documented M184V variant

• Receiving stable ART.

Exclusion Criteria:

• Hep B

• HIV-1 genotype for 4 protease inhibitors

• HIV-1 genotype positive for 2 NNRTI mutations

• Previous therapy with system myelosuppressive potential within 3 months of study start

• Use of Epogen or Neupogen

• History of cirrhosis

• Alcohol or drug dependence

• Inability to tolerate oral medication

• Women who are pregnant or breast feeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• elvucitabine

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States,